Impressed by the success of the UK's comparative effectiveness health care agency NICE, Medicare payment expert Gail Wilensky is pushing for a similar body in the U.S. - and at least one major stakeholder, Johnson & Johnson, appears willing to entertain the idea.

"I am driven by concern over what happens if we don't get this excess spending growth to slow down," Wilensky said at a Feb. 14 forum sponsored by America's Health Insurance Plans, the Health Industry Forum and Kaiser Permanente. Wilensky headed the Health Care Financing Administration (now CMS) from 1990 to 1992 and chaired the Medicare Payment Advisory Commission from 1997 to 2001.

The National Institute for Health and Clinical Excellence, or NICE, has informed national coverage of devices and drugs in the United Kingdom since 1999.

The government-funded, independent agency sponsors evidence reviews comparing the effectiveness of selected medical technologies, using the results to create clinical guidelines and make coverage recommendations. Through its analyses, NICE has been able to prevent overuse of inappropriate and ineffective technology, supporters say.

Wilensky, now a senior fellow at the international health education foundation Project HOPE, envisions a similar center in the U.S. that would analyze the comparative clinical effectiveness of devices, drugs and medical procedures.

Industry Says Concept Could Drive Innovation

While some have been surprised to see members of industry get behind an idea intended to reduce health care spending in the U.S., Wilensky said that "many of the large, especially innovative pharmaceutical [and] device companies are not finding this terribly threatening because, in fact, they're ... providing information like this at least in the European markets if they want [their products] to be sold."

Stuart Altman, dean of the Heller School for Social Policy & Management at Brandeis University, explained that using comparative effectiveness data to slow Medicare growth is preferable to "easy" fixes such as spending limits, age limits and coverage denials - methods that "restrict on a rather arbitrary basis who gets what," Altman said.

Johnson & Johnson VP-Health Policy Kathy Buto agreed that an evidence-based approach would be favorable to those kinds of "draconian cost containment approaches."

Moreover, an emphasis on comparative effectiveness could spur product innovation to improve standards of care, Buto said. "It will really just raise the level of the game to cause more of the research to be directed, we think, to those things that matter."

Jack Rowe, a professor at the Columbia University Mailman School of Public Health and CEO of Aetna from 2000 to 2006, recently visited NICE in London and said, "One of the things they were most positive about when I was there was how helpful and knowledgeable the people from industry are who are on their advisory committee."

Johnson & Johnson participates in some of NICE's advisory groups, and according to Buto, this kind of stakeholder involvement has contributed to industry's support of the agency's decisions.

"Fourth Hurdle" For Products?

However, Buto highlighted some red flags from an industry perspective about involving a comparative effectiveness agency in U.S. coverage processes. "Fundamentally in the industry - both device and pharmaceutical - there's a big concern that actually this is a stalking horse for what's known as a fourth hurdle, or actual impediment to getting new treatments to patients," she said.

According to Wilensky, a technology review at NICE adds 18 months "over and above the FDA type of safety and efficacy" review.

Buto noted that payers in the United Kingdom generally wait to cover new technologies until NICE makes a recommendation, even though they are not required to do so. From her perspective, CMS' coverage with evidence development policy is a more favorable model for the government to require that additional data be collected while covering promising technologies and allowing them to diffuse.

In addition, Buto cautioned that comparative effectiveness data collection under a new type of center should not duplicate existing study requirements from FDA and CMS.

She suggested that firms be offered streamlined regulatory approval or higher reimbursement as inducements to develop products that demonstrate meaningful improvements in care.

While stakeholders expect payers to jump on the information that a comparative effectiveness center in the U.S. would produce, industry would be concerned that the center not be tied too closely to coverage and payment decision-making. Buto stressed that such a center should "not be looked at as a vehicle really to just get a payer agenda taken care of."

On the other hand, Rowe said he would like to mandate that CMS follow any recommendations that come out of the comparative effectiveness center. In the UK, the National Health Service is required to follow NICE's coverage recommendations within three months, he noted.

Another aspect of NICE that may not translate as easily to the United States is the incorporation of cost-effectiveness into recommendations. Rowe, Wilensky and others agreed that "value" information is what payers want most.

However, Wilensky believes cost information should be assessed outside of the envisioned comparative effectiveness agency to protect it from backlash.

The Agency for Healthcare Research and Quality began conducting comparative effectiveness reviews in 2005, funded under a provision in the Medicare Modernization Act. So far, AHRQ has released seven final reports synthesizing available data on treatment options including breast cancer diagnostics and interventions for gastroesophageal reflux disease.

AHRQ's Effective Healthcare Program, under which the reviews are conducted, receives $15 million in annual funding.

However, the comparative effectiveness center that the panelists envision would ultimately require "billions of dollars" in annual investment, Wilensky said, and at least $100 million to $150 million just to get going. In the United States' budget-tight environment, Congress has yet to endorse comparative effectiveness research on such a scale.

- Chloe Taft (c.taft@elsevier.com)

Medicare Experts Mull Idea Of U.S. Comparative Effectiveness Review Agency

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